safety of d-lactate producing probiotics

Conditions: Acidosis

Summary: in this study the investigators want to test the safety of d-lactate producing probiotics in babies from birth to 1 month of age. previous data demonstrated no increase in urinary d-lactate in 4 month old infants supplemented with d-lactate producing probiotics. the primary purpose of this study is to evaluate the influence of d-lactate producing probiotics on d-lactate excretion in young infants during the neonatal period (days 0 - 28).

lactate, in addition to being found in more common fermented foods of today, such as yogurt, lactate, in its two stereoisomer forms, known as the d (dextrorotary) or l (levorotary) is also produced in the colon through the normal fermentative process of lactic acid producing bacteria. both d-lactate and l-lactate produced by these microbes are metabolized by enzymes within human cells and do not typically pose an acid-base risk by reducing ph to a threatening degree in healthy individuals. however, the specific dehydrogenase that converts d-lactate to pyruvate is far less active than that for l-lactate, and it has been suggested that very young infants may be a vulnerable group for d-lactic acidosis. previous data have shown that urinary d-/l- lactate excretion were not significantly different between 2 groups of 4 month old infants taking a control formula or a formula containing d-lactate producing probiotics for 4 weeks. however, measures were not collected in babies during the first month after birth. in this study we want to test the safety of d-lactate producing bacteria in babies from birth to 1 month of age. this safety study is a randomized, controlled, single center, clinical trial of 2 groups of infants. the primary objective of this clinical trial is: to evaluate the effect of a starter formula containing d-lactate producing probiotics versus a starter formula without probiotics, on d-lactic acid urine levels in healthy formula-fed infants, from birth to 28 days of age. urinary d-lactate concentration (mmol/mol creatinine), will be measured at (baseline, 7 days, 14 days and 28 days). secondary objectives include evaluation of effects on gut microbiota, gastrointestinal tolerance, duration of sleep and crying, morbidity and growth, with a follow up to 6 months of age.

Eligibility criteria:
inclusion criteria: * healthy babies, full term (≥37 weeks gestation) who are 0-24 hours of age at enrolment. * babies anticipated to be exclusively formula-fed. * babies under the care of a paediatrician or other qualified healthcare professional and have had at least one postnatal visit. * study explained and written information provided to parent/caregiver demonstrating understanding of the given information. * informed consent signed (parent/legal representative) exclusion criteria: * babies with chromosomal or major congenital anomalies. * significant pre natal and/or post natal disease * babies receiving an antibiotic * babies born from mothers using supplemental probiotics during the last trimester of pregnancy and/or antibiotics during the last 14 days of pregnancy. * babies' family, of whom in the investigator's assessment, cannot be expected to comply with the protocol. * babies currently participating in another clinical study

Keywords: nutrition infant formula probiotics